VALCOPREP-100- diclofenac sodium, isopropyl alcohol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

Available from:

Plum Valley Pharma LLC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Purpose Arthritis pain reliever Uses - for the temporary relief of arthritis pain ONLY in the following areas: – hand, wrist, elbow (upper body areas) – foot, ankle, knee (lower body areas) - This product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If not pain relief in 7 days, stop use Do not use - if you have ever had an allergic reaction to any other pain reliever or to a fever reducer - for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. - right before or after heart surgery - on more than 2 body areas at the same time - in the eyes, nose or mouth Stop use and ask a doctor if - pain gets worse or last more than 21 days - redness or swelling is present in the painful area - fever occurs - skin irritation occurs - any new symptoms appear. These could be signs of a serious condition. - you experience any of the following signs of stomach bleeding - feel faint - have bloody or black stools - vomit blo

Product summary:

Diclofenac sodium topical gel, 1% is available in tubes containing 100 g of the topical gel in each tube. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%). 100 g tube NDC 70512-0106-10 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep from freezing. Store the dosing card with your diclofenac sodium topical gel.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VALCOPREP-100- DICLOFENAC SODIUM, ISOPROPYL ALCOHOL
PLUM VALLEY PHARMA LLC
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VALCOPREP-100
(NSAID) - ARTHRITIS PAIN RELIEVER
ACTIVE INGREDIENT
Diclofenac sodium (NSAID*) 1%
*nonsterodial anti-inflammatory drug
PURPOSE
Arthritis pain reliever
USES
for the temporary relief of arthritis pain ONLY in the following
areas:
– hand, wrist, elbow (upper body areas)
– foot, ankle, knee (lower body areas)
This product may take up to 7 days to work for arthritis pain; it is
not for immediate
relief. If not pain relief in 7 days, stop use
WARNINGS
FOR EXTERNAL USE ONLY
ALLERGY ALERT: Diclofenac may cause a severe allergic reaction,
especially in people
allergic to aspirin.
Symptoms may include:
• hives • asthma (wheezing) • skin reddening • blisters •
facial swelling • shock • rash
If an allergic reaction occurs, stop use and seek medical help right
away.
LIVER WARNING: This product contains diclofenac. Liver damage may
occur if you apply
• more or for a longer time than directed
• when using other drugs containing diclofenac
STOMACH BLEEDING WARNING: This product contain an NSAID, which may
cause severe
stomach bleeding. The chance is small but high but higher if you
• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or non-prescription
NSAIDs (aspirin,
ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• apply more or for longer than directed
HEART ATTACK AND STROKE WARNING: NSAIDs, except aspirin, increase the
risk of heart
attach, heart failure, and stroke. These can be fatal. The rish is
higher if you use more
than directed or for longer than directed.
DO NOT USE
if you have ever had an allergic reaction to any other pain reliever
or to a fever
reducer
for strains, sprains, bruises or sports injuries. This product has not
been shown to
work for these types of injuries.
right before or after heart surgery
on more th